Evaluation of Renvela in Patients With Chronic Kidney Disease Not On Dialysis And Hyperphosphatemia In China

Inclusion criteria

• Participants with chronic kidney disease who had not been on dialysis, and were not expected to begin dialysis, or renal transplantation in the next 4 months from the screening visit.
• Had serum phosphorus measurement greater than or equal to (>=) 5.5 mg/dL (1.78 mmol/L) at screening visit (if participants were not on phosphate binder[s] at Screening Visit) OR at the end of Washout Period (if participants were on phosphate binder[s] at screening visit).
• Had the following laboratory measurements at screening visit:
• 25-hydroxy vitamin D >=10 nanograms per milliliter (ng/mL).
• intact parathyroid hormone, intact parathyroid hormone (iPTH) <=800 picograms per millilitre (pg/mL).
• Signed written informed consent.

Exclusion criteria

• Men or women below 18 years of age.
• Any technical/administrative reason that made it impossible to randomize the participant in the study.
• Was not of the level of understanding and willingness to cooperate with all visits and procedures, as described in the study protocol.
• Not yet received chronic kidney disease diet education before screening visit.
• Not willing and not able to avoid changes to diet during the study.
• Not willing or able to maintain screening doses of lipid lowering medication, 1, 25 dihydroxy vitamin D, and/or cinacalcet for the duration of the study, except for safety reasons.
• Not willing or not able to avoid antacids and phosphate binders containing aluminium, magnesium, calcium, or lanthanum for the duration of the study unless prescribed as an evening calcium supplement.
• Had participated in any other investigational drug studies within 30 days, or 5 half lives, whichever is longer, prior to screening visit.
• Conditions/situations such as:
• Participant was the Investigator or any Subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
• Uncooperative or any condition that could make the participant potentially non-compliant to the study procedures (for example, participants could not be contacted by phones as required in phone call visits).
• Evidence of active malignancy.
• Not on stable medical condition (for example, but not limited to, active ethanol or drug abuse [tobacco use acceptable]; documented poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, human immunodeficiency virus [HIV] infection), or had any clinically significant medical conditions.
• Had known hypersensitivity to sevelamer or any constituents of Renvela tablets.
• Had bowel obstruction, active dysphagia or swallowing disorder, or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation.
• Using or plan to use anti-arrhythmic or anti-seizure medications for arrhythmia or seizure disorders.
• Was pregnant or breast-feeding.
• If the participant was female, and of childbearing potential (pre-menopausal and not surgically sterile), was not willing to use an effective contraceptive method throughout the study.
• Had any condition, which in the opinion of the investigator would prohibit the participant's inclusion in the study.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.